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CompletedNCT00267540Updated Jan 30, 2008

The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls

An interventional study of cholecalciferol (D3) (vitamin) in Vitamin D Deficiency, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 10 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-30.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
10 Years to 11 Years
Sex
Female
01

Study summary

Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13.

More specifically the effects on the following parameters will be assessed:

  • Vitamin D metabolites.
  • Parathyroid hormone.
  • Bone turnover.
  • Bone mineral accretion.
  • Serum calcium and phosphate.
  • Renal handling of calcium and phosphate.
Read the detailed description

This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.

02

Conditions studied

  • Vitamin D Deficiency

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Keywords

  • Vitamin D
  • adolescent girls
  • bone accretion
  • bone turn over
  • vitamin D status
  • Vitamin D insufficiency in young girls
03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 225 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 11 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg

Exclusion criteria

Exclusion Criteria:

  • Any chronical disease with influence on bone mass or turnover
  • Intake of drugs with influence on bone mass or turnover
  • Intake of calcium or vitamin D other than the intervention
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
225 participants

Interventions

  • Behavioralcholecalciferol (D3) (vitamin)
06

What researchers measure

Primary outcomes

  1. Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.

  2. Bone accretion measured by DXA. Measurement at baseline and after one year.

  3. Bone turnover measured at baseline, half a year and one year

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Study locations

1 site
  • Department of Human Nutrition, The Royal Veterinary and Agricultural University
    Frederiksberg, DK 1958, Denmark
08

References and documents

Publications

  • Cashman KD, FitzGerald AP, Viljakainen HT, Jakobsen J, Michaelsen KF, Lamberg-Allardt C, Molgaard C. Estimation of the dietary requirement for vitamin D in healthy adolescent white girls. Am J Clin Nutr. 2011 Mar;93(3):549-55. doi: 10.3945/ajcn.110.006577. Epub 2011 Jan 26. PubMed 21270380 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00267540
Lead sponsor
University of Copenhagen
Collaborators
Seventh Framework Programme
First posted
Dec 21, 2005
Start date
Jan 2001
Completion
Dec 2003
Last update
Jan 30, 2008

Study contacts

Christian Mølgaard, MD, PhD
principal investigator · The Royal Veterinary and Agricultural University, Frederiksberg, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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